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510(k) Data Aggregation

    K Number
    K132195
    Device Name
    EUROIMMUN ANTI-PLA2R ELISA (IGG)
    Manufacturer
    EUROIMMUN US INC
    Date Cleared
    2014-06-27

    (347 days)

    Product Code
    PGV
    Regulation Number
    866.5780
    Why did this record match?
    Applicant Name (Manufacturer) :

    EUROIMMUN US INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EUROIMMUN Anti-PLA2R ELISA (IgG) test kit is intended for the qualitative or semiquantitative determination of IgG class autoantibodies against phospholipase A2 receptor (PLA2R) in human serum. It is used as an aid in the diagnosis of primary membranous glomerulonephritis (pMGN), in conjunction with other laboratory and clinical findings.
    Device Description
    The EUROIMMUN Anti-PLA2R ELISA (IgG) consists of a microwell ELISA plate coated with PLA2R antigen, 5 calibrators, positive and negative control, peroxidase-labelled anti-human IgG conjugate, sample buffer, wash buffer concentrate, TMB chromogen/substrate solution and stop solution.
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    K Number
    K100017
    Device Name
    EUROIMMUN HIPPOCAMPUS/CEREBELLUM/GLUTAMATE RECEPTOR/IFA BIOCHIP MOSAIC TEST SYSTEM
    Manufacturer
    EUROIMMUN US INC
    Date Cleared
    2010-09-13

    (252 days)

    Product Code
    OSK
    Regulation Number
    866.5660
    Why did this record match?
    Applicant Name (Manufacturer) :

    EUROIMMUN US INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EUROIMMUN Anti-Glutamate receptor (type NMDA) IFA is intended for the qualitative determination of autoantibodies against glutamate receptor (type NMDA) in human serum. It is used as an aid in the diagnosis of anti-glutamate receptor (type NMDA) autoimmune encephalitis in conjunction with other laboratory and clinical findings.
    Device Description
    The EUROIMMUN IFA is an assay for standardized detection of anti-glutamate receptor (type NMDA) antibodies utilized in each laboratories familiar with indirect immunofluorescence. The non-transfected cells are used as a control to simplify differentiation of potential co-existing and non-specific reactivity such as ANA. The test kit consists of slides, which contain BIOCHIPs coated with glutamate receptor (type NMDA) transfected cells and non-transfected cells, fluorescein-labelled anti-human IgG (goat), a positive control for transforced volle and non new and of a negative control, a salt for preparation of PBS, Tween 20, embedding medium, cover glasses and an instruction booklet.
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    K Number
    K091969
    Device Name
    EUROIMMUN ANTI-DESMOGLEIN 1 ELISA (IGG), EUROIMMUN ANTI-DESMOGLEIN 3 ELISA (IGG)
    Manufacturer
    EUROIMMUN US INC
    Date Cleared
    2010-09-02

    (428 days)

    Product Code
    NBO
    Regulation Number
    866.5660
    Why did this record match?
    Applicant Name (Manufacturer) :

    EUROIMMUN US INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EUROIMMUN Anti-Desmoglein 1 ELISA (IgG) test kit is intended for the qualitative or semi-quantitative determination of IgG class autoantibodies against desmoglein 1 in human serum and plasma. It is used as an aid in the diagnosis of pemphigus .foliaceus (PF), in conjunction with other laboratory and clinical findings. The EUROIMMUN Anti-Desmoglein 3 ELISA (IgG) test kit is intended for the qualitative or semi-quantitative determination of IqG class autoantibodies against desmoqiein 3 in human serum and plasma. It is used as an aid in the diagnosis of pemphigus vulgaris (PV), in conjunction with other laboratory and clinical findings.
    Device Description
    Not Found
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    K Number
    K092736
    Device Name
    EUROIMMUN ANTI-M2-3E ELISA (IGG)
    Manufacturer
    EUROIMMUN US INC
    Date Cleared
    2010-09-02

    (363 days)

    Product Code
    DBM
    Regulation Number
    866.5090
    Why did this record match?
    Applicant Name (Manufacturer) :

    EUROIMMUN US INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EUROIMMUN Anti-M2-3E ELISA (IgG) test kit is intended for the qualitative or semi-quantitative determination of IgG class autoantibodies against the mitochondrial antigens M2 in human serum and plasma. It is used as an aid in the diagnosis of primary billary cirrhosis (PBC), in conjunction with other laboratory and clinical findings.
    Device Description
    The EUROIMMUN Anti-M2-3E ELISA (IgG) consists of a microwell ELISA plate coated with M2-3E antigen, 3 calibrators, positive and negative control, peroxidase-labelled anti-human IgG conjugate, sample buffer, wash buffer concentrate, TMB chromogen/substrate solution and stop solution.
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    K Number
    K083053
    Device Name
    EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGG)
    Manufacturer
    EUROIMMUN US INC
    Date Cleared
    2009-08-07

    (297 days)

    Product Code
    MST
    Regulation Number
    866.5750
    Why did this record match?
    Applicant Name (Manufacturer) :

    EUROIMMUN US INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Anti-Gliadin (GAF-3X) ELISA (IgG) test kit is intended for the qualitative or semi-quantitative determination of IgA class antibodies against gliadin in human serum. It is used as an aid in the diagnosis of gluten-sensitive enteropathy (celiac disease) and dermatitis herpetiformis Duhring, in conjunction with other laboratory and clinical findings.
    Device Description
    Not Found
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    K Number
    K083052
    Device Name
    EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGA)
    Manufacturer
    EUROIMMUN US INC
    Date Cleared
    2009-07-28

    (287 days)

    Product Code
    MST
    Regulation Number
    866.5750
    Why did this record match?
    Applicant Name (Manufacturer) :

    EUROIMMUN US INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Anti-Gliadin (GAF-3X) ELISA (IgA) test kit is intended for the qualitative determination of IgA class antibodies against gliadin in human serum. It is used as an aid in the diagnosis of gluten-sensitive enteropathy (celiac disease) and dermatitis herpetiformis Duhring, in conjunction with other laboratory and clinical findings.
    Device Description
    Not Found
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    K Number
    K083850
    Device Name
    EUROIMMUN ANCA IFA EUROPLUS GRANULOCYTE BIOCHIP MOSAIC TEST SYSTEMS
    Manufacturer
    EUROIMMUN US INC
    Date Cleared
    2009-05-20

    (147 days)

    Product Code
    MOB
    Regulation Number
    866.5660
    Why did this record match?
    Applicant Name (Manufacturer) :

    EUROIMMUN US INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K083381
    Device Name
    EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG)
    Manufacturer
    EUROIMMUN US INC
    Date Cleared
    2009-04-15

    (152 days)

    Product Code
    LRM
    Regulation Number
    866.5100
    Why did this record match?
    Applicant Name (Manufacturer) :

    EUROIMMUN US INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EUROIMMUN Anti-dsDNA-NcX ELISA (IgG) test kit is designed for the quantitative or qualitative determination of IgG class autoantibodies against double-stranded genomic DNA (dsDNA) in human serum and EDTA or citrate plasma. It is used as an aid in the diagnosis of systemic lupus erythematosus, in conjunction with other laboratory and clinical findings.
    Device Description
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    K Number
    K082130
    Device Name
    EUROIMMUN ANTI-PR3-HN-HR ELISA (IGG)
    Manufacturer
    EUROIMMUN US INC
    Date Cleared
    2009-04-07

    (252 days)

    Product Code
    MOB
    Regulation Number
    866.5660
    Why did this record match?
    Applicant Name (Manufacturer) :

    EUROIMMUN US INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EUROIMMUN Anti-PR3-hn-hr ELISA (IgG) test kit is intended for the qualitative or semiquantitative determination of IgG class autoantibodies against proteinase 3 (PR3) in human serum, EDTA plasma, lithium heparin plasma and citrate plasma. It is used as an aid in the differential diagnosis of Wegener's granulomatosis and other autoimmune vasculitides, in conjunction with other laboratory and clinical findings.
    Device Description
    Not Found
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    K Number
    K083615
    Device Name
    EUROIMMUN ANTI BP 180-4X ELISA (IGG)
    Manufacturer
    EUROIMMUN US INC
    Date Cleared
    2009-03-16

    (98 days)

    Product Code
    OEG
    Regulation Number
    866.5660
    Why did this record match?
    Applicant Name (Manufacturer) :

    EUROIMMUN US INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EUROIMMUN Anti-BP180-4X ELISA (IgG) test kit is intended for the qualitative or semiquantitative determination of IgG class autoantibodies against BP180 in human serum and plasma. It is used as an aid in the diagnosis of bullous pemphigoid (PB), in conjunction with other laboratory and clinical findings.
    Device Description
    Not Found
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